Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis

NCT05708157 — Unknown, 240 participants, Gachon University Gil Medical Center

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Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid

RegistryNCT05708157, acronym INCS/INAH
StatusUnknown
Study typeObservational
Enrollment240 (Estimated)
SponsorGachon University Gil Medical Center (Other); collaborators: Hallym University Kangnam Sacred Heart Hospital, Gangneung Asan Hospital, Bundang Jesaeng Hospital, Chung-Ang University Gwangmyeong Hospital, Hallym University Medical Center
ConditionsAllergic Rhinitis
Interventionsconcomitant intranasal antihistamine and corticosteroid (Drug)
Datesstart 2023-01-17, primary completion 2024-02-29 (estimated), completion 2024-02-29 (estimated), first posted 2023-02-01, last updated 2023-02-01
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Allergic Rhinitis All trials of concomitant intranasal antihistamine and corticosteroid

-Summary

Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \[VAS\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. After 2-week treatment, changes in clinical parameters including VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be evaluated.

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+Detailed description

Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \[VAS\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid. In addition to VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be measured before treatment (baseline) and 2 week after treatment. The differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p<0.05 was considered statistically significant.

+Arms and interventions

ArmTypeInterventionsDescription
Active groupDrug: concomitant intranasal antihistamine and corticosteroidPatients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.
  • concomitant intranasal antihistamine and corticosteroid (Drug): concomitant intranasal administration with antihistamine and corticosteroid

+Outcome measures

Primary outcomes

  • TNSS [2 week]: total nasal symptom score

Secondary outcomes

  • TOSS [2 week]: total nasal symptom score
  • RQLQ [2 week]: rhinoconjunctivitis quality-of-life questionnares
  • VAS [2 week]: visual analogue scale

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

* Perinnial allergic rhinitis diagnosed by a doctor
* Positive for one or more of inhalant perinneal allergen in skin prick test or serum specific IgE measurement
* Age: 19 years or older
* Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasal corticosteroid

Exclusion Criteria:

* Compliance for one or more drugs in last 2 weeks: <80%
* Use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks
* Initiation of allergen-specific immunotherapy in last 12 months
* Seasonal allergic rhinitis
* Chronic rhinosinusitis other than allergic rhinitis
* Nasal polyposis
* Comorbid diseases including infectious, respiratory, cardiologic, renal, gastrointestinal, endocrinologic, oncologic, hemotologic and immunologic disorders which investigators judge to affect on the study significantly.
* Patients' rejection
* Pregenancy or lactation

+Locations (1)

FacilityCityCountryStatus
Gachon University Gil Medical CenterIncheonSouth KoreaRecruiting

+Publications

  • Kim M, Ryu G, Kang SY, Kim MA, Yang SI, Lee IH, Choi GS, Kim HJ, Lee SM, Kim DK, Choi JH, Yang HJ, Kim SW; Work Group for Rhinitis, the Korean Academy of Asthma, Allergy and Clinical Immunology. Intranasal antihistamine and corticosteroid to treat allergic rhinitis: A systematic review and meta-analysis. Allergy. 2022 Nov;77(11):3436-3440. doi: 10.1111/all.15415. Epub 2022 Jul 8. No abstract available. PMID 35716356

+Investigators